Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease

Study Purpose

This study aims to investigate how knowledge of gluten immunogenic peptide (GIP) levels in
stool and urine affects subsequent adherence to a gluten-free diet. Half of the participants
will receive results in real-time using a home device and the other half will store samples
to be tested at the end of the 30 week study. Participants will also have a diet review with
a dietitian at the beginning of the end of their study and be asked questions about their
symptoms, gluten-free diet adherence and quality of life.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Interventional

Eligible Ages

6 Years - 18 Years

Gender

All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age 6 to 18 years at study entry
- Diagnosis of celiac disease based upon either
1.

Exclusion Criteria:

- Unable to provide urine and/or stool sample or attend study visits
- English proficiency unsuitable for completion of surveys
- Anuria or oliguria
- Reliance upon commercial gluten-free formulas as primary source of nutrition
- Comorbid condition that in the opinion of the investigator would interfere with the
subject's participation in the study or would confound the results of the study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Following a gluten-free diet is difficult. Eating small amounts of gluten may be common.
Gluten may cause a wide range of symptoms, or no symptoms at all. Thus, there is not always a
'feedback loop' to alert to accidental gluten exposure. Nevertheless, these "silent" gluten
exposures may interfere with recovery and healing of the intestine. New tools are available
to test for fragments of gluten

- Gluten Immunogenic Peptides (GIPs) in urine and stool.

The goal of this research study is to evaluate how knowledge of gluten-immunogenic peptide
(GIP) levels in urine and stool affects subsequent adherence to a gluten-free diet.
Participants will be children with celiac disease recruited at Boston Children's Hospital.
All participants will undergo a diet assessment by a dietitian at the beginning and end of
the study. At random intervals, participants will be prompted to collect their next urine
sample and complete a survey related to symptoms and diet adherence. Half of the participants
will store the sample to be tested later and the rest of the participants will be provided
with devices to test their urine at home to receive immediate results. Participants in the
home testing group will also be given a set of stool tests (x4) to use at their own
discretion during the study period, and will report results and reasons for test use to the
research team. GIP test results will be compared to other measures of celiac disease and
gluten-free diet adherence, including antibody tests. These findings will help to determine
how these new tools can be used to improve gluten-free diet adherence and symptoms and the
effect on quality of life.

Arms & Interventions

Arms

Experimental: Open Results with home testing

Participants in the open results arm will be provided with Gluten Detective home testing kits (immunochromatographic lateral flow tests) at week 8 of the study for immediate qualitative (yes/no) feedback about the presence of biomarkers of gluten in their stool and/or urine. During the period from week 8 to week 30, participants will be contacted a total of 6 times at random intervals to collect and test urine samples and complete a questionnaire.Additionally, participants will be given 4 stool test kits, with instructions that they may use these at times of their choosing and will report results and reasons for test use, if any. During this time participants will also keep a diary of suspected gluten exposures. All samples collected will be returned during the week 30 study visit.

No Intervention: Blinded (sample collection only)

Participants in the blinded arms will not be given a test kit but will be given sample collection materials. During the period from week 8 to week 30 of the study, participants will be contacted a total of 6 times at random intervals, instructed to collect urine samples, and complete a questionnaire. Participants will also keep a diary of suspected gluten exposures. All samples collected will be returned during the week 30 study visit. After completion of sample collection, all participants will be unblinded and notified of the results once the samples have been processed.

Interventions

Device: - Immunochromatographic lateral flow test

The immunochromatographic lateral flow test (Gluten Detective) is an at-home test that detects gluten immunogenic peptides excreted in stool or urine. This test can detect gluten exposures which occurred either during the last 24 hours (urine) or within up to a 7 day window (stool). Minimum intake amounts of gluten for successful detection using these test are 50mg (stool) to 500mg (urine)

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